Among the European countries, Denmark is only surpassed by France when it comes to gathering the proportionately largest number of reports on side effects from medicine. Yet, 2000 reports a year from healthcare professionals is not good enough compared to the fact that every other Dane believes to have experienced a side effect from medicine.
The Danish Medicines Agency would therefore like some assistance from medicine users and healthcare professionals alike. We encourage them to keep their eyes open to side effects and report them to us.
On this basis, the Danish Medicines Agency’s participated actively in the Danish Medical Association’s conference on side effects in September. Here, the Danish Medicines Agency’s Chief Executive Officer, Jytte Lyngvig, said that too many side effects are forgotten.
Too few side effects are reported
”We are certain that the extent of underreporting is significant. Last year we received nearly 2000 reports from doctors, dentists and veterinarians,” she said.
Jytte Lyngvig contrasted this figure with the fact that more than 10,000 doctors in Denmark can prescribe medicine – and that each Dane on average uses around one and a half dose of medicine a day. Therefore, she encouraged Danish doctors to make a greater effort.
“If doctors fail to participate actively, it places patients and pharmaceutical companies – and thereby also citizens – in a bad position,” she said.
Reports from patients may reveal new side effects
A recent PhD thesis supported by the Danish Medicines Agency demonstrates that spontaneous reporting of adverse reactions is especially suited for revealing unexpected problems related to a medicinal product. The reason being that when scientists specifically search for side effects from a medicine, they typically only find known side effects. New, and potentially dangerous, side effects are often discovered by doctors and by the patients themselves.
Citizens contribute to an increasing extent – in 2007, the share of adverse reaction reports from patients and relatives doubled.
Information about side effects must be publicly available
The Danish Medicines Agency wishes to make as much information as possible about side effects publicly available. We are therefore in the process of developing a database in which doctors, scientists and laymen can see the side effects reported to the Danish Medicines Agency. However, personal information is removed before the information is published.
The aim is to create a database of such quality that it can be used directly by doctors and scientists and which is also so easy to understand that it can be read by anyone. Information about the known effects and side effects of a medicinal product appear in the approved summary of product characteristics, which can be found at www.produktresume.dk.
Obligation for doctors
The requirements are unambiguous: under the executive order on the reporting of adverse drug reactions from medicinal products etc. of 12 December 2005, doctors are under an OBLIGATION to report and patients have the OPTION to report:
Doctors, dentists and veterinarians must submit an adverse reaction report to the Danish Medicines Agency concerning all suspected side effects in the humans or animals they treat. For medicinal products authorised by a marketing authorisation from the Danish Medicines Agency or the European Commission and homeopathic medicinal products, the obligation to report ALL adverse reactions only concerns the first two years after the medicinal product is actually placed on the market. After this, they must report all serious or unexpected adverse reactions.
Other healthcare professionals, patients, relatives and animal owners may submit an adverse reaction report to the Danish Medicines Agency concerning all suspected side effects from medicinal products.
The same executive order establishes that a report to the Danish Medicines Agency MUST contain the following information: The name of the suspected medicinal product or active substance. A description of the suspected adverse drug reaction or any other reaction to the substance. The patient’s age, gender and initials. As well as the name of the person submitting the adverse drug reaction report.
Report side effects from medicine
Patients and doctors alike can report side effects from medicine here at the Danish Medicines Agency’s website (see “Report a side effect” in the factbox to the right).
Danish Medicines Agency, 1 October 2008